AkdÄ: Änderung des Wortlauts von Fach- und Gebrauchsinformationen – Empfehlungen des PRAC.

Zusammenfassung

6 April 2021 1 Pharmacovigilance Risk Assessment Committee (PRAC) New product information wording – Extracts from PRAC recommendations on signals Adopted at the 8-11 March 2021 PRAC The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals’ which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals. It can be found here (in English only). Ne

Kerninformationen

Drug reaction with eosinophilia and systemic symptoms (DRESS) has rarely been reported in patients treated with Kineret, predominantly in patients with systemic juvenile idiopathic arthritis (sJIA). Patients with DRESS may require hospitalization, as this condition may be fatal. If signs and symptom...

liveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone [phone] An agency of the European Union © European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. Drug reaction with eosinophilia and...

red. 2. What you need to know before you use <product name> - Anakinra Contact your doctor immediately - if you have ever developed an atypical, widespread rash or skin peeling after taking Kineret. The serious skin reaction, DRESS (drug reaction with eosinophilia and systemic symptoms), has rarely...

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